Medical Sharks

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Shark cartilage has been a mainstay in health food stores since 1993, when it was featured on CBS-TV’s “60 Minutes.” That segment, narrated by Mike Wallace, highlighted a Cuban study of supposedly terminal cancer patients who were shown doing exercises and “feeling better” several weeks after they began receiving shark cartilage preparations. The show also promoted the claims of biochemist/entrepreneur I. William Lane, known best as co-author of Sharks Don’t Get Cancer, a book that touts shark cartilage as a substance that stops tumor growth.

Never mind that sharks do get cancer, even cancer of the cartilage. But largely because of the “60 Minutes” hype, public demand for cartilage preparations mushroomed. Capitalizing on the boom, Lane’s son, Andrew, in 1994 founded Lane Labs-USA to manufacture and distribute the stuff.

Sales have been brisk, but Lane Labs has now had its comeuppance. A U.S. District judge has ordered the company to stop selling shark cartilage under its current name, BeneFin, or any other name. He also ruled that the company must destroy its inventory of the cartilage, except for a small quantity that may be needed for further research, and must refund money to anyone who has purchased the product since September, 1999.

Shark cartilage sales had continued to flourish long after its “60 Minutes” debut, despite the fact that scientific studies failed to demonstrate its value. In 1997, for example, researchers reported a trial on the effects of shark cartilage treatment for 58 people with advanced cancer. They found it to be “inactive” in patients with breast, colon, lung and prostate cancer. Similar findings were reported in a Danish study that saw no improvement in 17 women with breast cancer who had been given shark cartilage capsules for three months.

The results hardly came as news to Dr. Stephen Barrett, who in his Quackwatch Website has been highly critical of shark cartilage pushers. “William Lane’s promotions,” he says, “were based on the theory that shark cartilage could stop tumor growth by inhibiting the growth of new blood vessels around the tumor. However, there’s no reason to believe that ingesting capsules of powdered shark cartilage will do this because the relevant proteins will be digested rather than absorbed intact.”

Still, Lane Labs could have probably continued its shark cartilage scam if it had labeled the stuff as a “dietary supplement” and promoted it more subtly. Under the notorious Dietary Supplement Health and Education Act (DSHEA) of 1994, passed largely at the behest of the health food industry, this kind of restraint might have exempted cartilage preparations from jurisdiction by the Food and Drug Administration. Under DSHEA’s provisions, the FDA, with few exceptions, is not allowed to regulate dietary supplements. But Lane Labs has promoted the cartilage as effective in treating cancer. This, said the FDA, “by definition” made the cartilage and another Lane product not dietary supplements, but “drugs, new drugs and misbranded drugs” and enabled the agency to lower the boom.

It’s not that Lane hadn’t received prior warnings of its wrongdoing. They failed to take corrective action after receiving an FDA warning in 1997. And in 2000, the Federal Trade Commission charged that in its advertising it had made unsubstantiated claims that BeneFin and another product were effective against cancer. At the time, Lane Labs agreed to a $1 million settlement, $550,000 to the FTC and $450,000 to finance a shark cartilage study. But, undaunted, it continued its dishonest promotion of BeneFin. In the new U.S. District Court ruling, the presiding judge described the Lane principals as untrustworthy and issued a permanent injunction against misrepresenting any product in the future. “Defiance of this order,” says Dr. Barrett, “would be likely to result in imprisonment.” That should make other sharks in the dietary supplement business — and their numbers are legion — sit up and take notice.